The importance of an inclusive study design – the HepCAPP Study

Dr Kirsty Roberts

 

 

by Dr Kirsty Roberts, Senior Lecturer in Trials Methodology and Deputy Research Director EDI, Bristol Medical School, University of Bristol

Background

HepCAPP (Hepatitis C Case-finding in Primary Care Pilot) was a pilot oral swab Hepatitis C Virus (HCV) screening study which was funded by NHS England in 2019 and completed in 2023. The study invited over 98,000 people aged 40-64 registered at selected GP practices to take part. 12,216 (12.4%) consented and returned their sample to the UK Health Security Agency (UKHSA) for testing.

The study participants found the approach to testing acceptable and the uptake was better than expected. However, the study also confirmed that those identified could have been found through lower-cost targeted screening. Therefore, we recommended that oral swab HCV screening shouldn’t be rolled out in the NHS.

Were there any groups of people or communities under-represented?

The study found that those consenting to take part were from least deprived communities and 94.6% were of white ethnicity. The general practices taking part were in three geographical locations: the South-West, Yorkshire and Humber, and South London. The study recruited a significantly higher number of participants in the South-West compared to the other regions, which we believe contributed to us not recruiting a sample representative of the UK population.

What does this mean in terms of generalisability of the results?

As our sample was not entirely reflective of the UK population it may have reduced the accuracy and translatability of the research. There may have been differences between different groups which we couldn’t identify and our approach to testing may not have been deliverable to certain groups due to language barriers, for example, which could lead to health inequalities being maintained or increased.

How could we have made the study more inclusive?

1. Considered geographical locations which were more diverse, including areas under-served by research.

2. Produced an Easy-Read invitation letter and translated study documents. This would have improved the accessibility for some.

3. Recruited a more diverse Patient and Public Involvement and Engagement (PPIE) group. Our PPIE group consisted of seven individuals from different socio-economic backgrounds, however, they were all White ethnicities.

4. Used the data collected on participant demographics to monitor the diversity of the sample recruited at set times throughout the study and set realistic goals.

5. Budgeted for inclusion by adding extra resources to include general practices from more diverse geographical areas, including those that may have less research experience. Adding resources to develop inclusive study documents and dissemination materials.

Research Inclusion is now a condition of funding for all NIHR Domestic Programmes and Applied Research Collaboration (ARC) Calls – November 27th 2024.

Read the HePCAPP paper.

Tools and recommendations

How should trial teams make decisions about the proportions and diversity of ethnic groups in their trials?

‘Budgeting for Inclusion’ section of the Equality, Diversity and Inclusion Toolkit from the Research Support Service.

Accessible images recommendations

Acknowledgements

This blog was reproduced with permission from the NIHR Health Protection Research Unit in Behavioural Science and Evaluation at the University of Bristol

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